Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
1563 participants
OBSERVATIONAL
2014-02-28
2018-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Participants With 2 Years Follow up
Participants with NIRS-IVUS imaging at baseline and assigned to follow up for Non-Index Culprit Lesion related Major Adverse Cardiac Events (NC-MACE) for 2 years
NIRS-IVUS Imaging (TVC Imaging System)
Diagnostic Imaging Catheter
Interventions
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NIRS-IVUS Imaging (TVC Imaging System)
Diagnostic Imaging Catheter
Eligibility Criteria
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Inclusion Criteria
* Greater than 18 years of age.
* Clinical presenting symptoms meeting one of the three criteria below:
1. Subjects presenting with an acute coronary syndrome (ACS) including at least one of the following:
1. Elevated cardiac biomarkers with CK-MB or troponin greater than upper limits of normal;
2. ST depression or ST elevation \>1mm in 2 or more contiguous leads in the absence of LVH, paced rhythm, BBB or early repolarization;
3. A stabilized patient 24 to 72 hours post STEMI;
2. Unstable angina pectoris;
3. Stable angina pectoris and/or a positive functional study with evidence of ischemia.
* At least one Suspected Index Culprit Lesion requiring imaging with IVUS and/or NIRS for clinical indications.
* At least two native epicardial coronary arteries (which may include the Suspected Index Culprit Artery) eligible for imaging with NIRS-IVUS.
IVUS/NIRS Imaging Inclusion Criterion
* A minimum of a total 50 mm of coronary artery not involved in a prior or Index Procedure PCI (including the 5mm borders on either edge of the site receiving PCI) must be scanned. This 50mm total length may include contributions from the Suspected Index Culprit Arteries and from Index Non-Culprit Arteries. This total length must include contributions from two or more native imaged arteries.
Exclusion Criteria
* History of CABG or planned CABG within 6 months following NIRS-IVUS imaging.
* Patient has additional lesion(s) that needs a staged PCI.
* Subject life expectancy is less than 2 years at time of index catheterization.
* Subject with ejection fraction (EF) \<30%.
* Subject pacemaker dependent/paced rhythm.
* Subject pregnant and lactating.
* Any other factor that the investigator feels would put the patient at increased risk or otherwise make the patient unsuitable for participation in the protocol
* Patients undergoing performance of PCI in all three major vessels during the index PCI.
ALL
No
Sponsors
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Medstar Health Research Institute
OTHER
Infraredx
INDUSTRY
Responsible Party
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Principal Investigators
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Ron Waksman, MD
Role: PRINCIPAL_INVESTIGATOR
MedStar Heart Institute
Locations
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University of California Los Angeles Medical Center
Los Angeles, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
JFK Medical Center
Atlantis, Florida, United States
Delray Medical Center
Delray Beach, Florida, United States
Palmetto General Hospital
Hialeah, Florida, United States
Florida Hospital Orlando
Orlando, Florida, United States
Palm Beach Gardens Medical Center
Palm Beach Gardens, Florida, United States
Memorial Hospital West
Pembroke Pines, Florida, United States
Emory Midtwon
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Alexian Brothers Heart and Vascular Institute
Elk Grove Village, Illinois, United States
St. John's Springfield
Springfield, Illinois, United States
Community Heart & Vascular
Indianapolis, Indiana, United States
Methodist
Merrillville, Indiana, United States
Central Baptist Hospital
Lexington, Kentucky, United States
McLaren Bay Region
Bay City, Michigan, United States
St. John's
Detroit, Michigan, United States
McLaren-Macomb
Mount Clemens, Michigan, United States
Crittenton Hospital
Rochester, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Columbia University
New York, New York, United States
LIJ Health System
New York, New York, United States
New York Presbyterian Hospital Cornell
New York, New York, United States
Metrohealth
Cleveland, Ohio, United States
Hillcrest Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Medical Branch
Galveston, Texas, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
Heart Hospital Plano
Plano, Texas, United States
Davis Hospital and Medical Center
Layton, Utah, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
San Biovanni Hospital
Rome, , Italy
Latvian Centre of Cardiology
Riga, , Latvia
Academic Medical Center
Amsterdam, , Netherlands
Radboud University Medical Centre
Nijmegen, , Netherlands
Erasmus Medical Centre
Rotterdam, , Netherlands
Maasstad Ziekenhuis
Rotterdam, , Netherlands
SUSCCH, a.s.
Banská Bystrica, , Slovakia
Golden Jubilee National Hospital
Clydebank, , United Kingdom
University of Edinburgh
Edinburgh, , United Kingdom
Royal Brompton Hospital
London, , United Kingdom
Countries
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References
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Waksman R, Torguson R, Spad MA, Garcia-Garcia H, Ware J, Wang R, Madden S, Shah P, Muller J. The Lipid-Rich Plaque Study of vulnerable plaques and vulnerable patients: Study design and rationale. Am Heart J. 2017 Oct;192:98-104. doi: 10.1016/j.ahj.2017.02.010. Epub 2017 Feb 16.
Waksman R, Di Mario C, Torguson R, Ali ZA, Singh V, Skinner WH, Artis AK, Cate TT, Powers E, Kim C, Regar E, Wong SC, Lewis S, Wykrzykowska J, Dube S, Kazziha S, van der Ent M, Shah P, Craig PE, Zou Q, Kolm P, Brewer HB, Garcia-Garcia HM; LRP Investigators. Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study. Lancet. 2019 Nov 2;394(10209):1629-1637. doi: 10.1016/S0140-6736(19)31794-5. Epub 2019 Sep 27.
Torguson R, Mintz GS, Di Mario C, Ten Cate T, Ali ZA, Singh V, Skinner W, Zhang C, Shea C, Kuku KO, Garcia-Garcia HM, Waksman R. Disparities among Black and White patients in plaque burden and composition and long-term impact. Cardiovasc Revasc Med. 2023 Oct;55:28-32. doi: 10.1016/j.carrev.2023.04.023. Epub 2023 May 1.
Case BC, Torguson R, Mintz GS, Di Mario C, Medranda GA, Zhang C, Shea C, Garcia-Garcia HM, Waksman R. Additive Effect of Multiple High-Risk Coronary Artery Segments on Patient Outcomes: LRP Study Sub-Analysis. Cardiovasc Revasc Med. 2023 Jan;46:38-43. doi: 10.1016/j.carrev.2022.08.008. Epub 2022 Aug 6.
Torguson R, Mintz GS, Case BC, Di Mario C, Zhang C, Shea C, Garcia-Garcia HM, Waksman R. Correlation between lipidic content and arterial-wall plaque burden: A Lipid Rich Plaque study sub-analysis. Int J Cardiol. 2022 Nov 1;366:32-34. doi: 10.1016/j.ijcard.2022.07.024. Epub 2022 Jul 13.
Case BC, Shea C, Torguson R, Zhang C, Yerasi C, Medranda GA, Kuku KO, Garcia-Garcia HM, Mintz GS, Waksman R. Impact of Baseline Imaging of Non-Culprit Coronary Lesions on Adverse Events: Insight From LRP Study. Cardiovasc Revasc Med. 2022 Jun;39:1-5. doi: 10.1016/j.carrev.2021.12.012. Epub 2021 Dec 13.
Torguson R, Shlofmitz E, Mintz GS, Mario CD, Cate TT, Ali ZA, Singh V, Skinner W, Zhang C, Shea C, Garcia-Garcia HM, Waksman R. Frequency of Lipid-Rich Coronary Plaques in Stable Angina Pectoris versus Acute Coronary Syndrome (from the Lipid Rich Plaque Study). Am J Cardiol. 2021 Nov 1;158:1-5. doi: 10.1016/j.amjcard.2021.07.033. Epub 2021 Aug 28.
Bambagioni G, Di Mario C, Torguson R, Demola P, Ali Z, Singh V, Skinner W, Artis A, Cate TT, Zhang C, Garcia-Garcia HM, Doros G, Mintz GS, Waksman R. Lipid-rich plaques detected by near-infrared spectroscopy predict coronary events irrespective of age: A Lipid Rich Plaque sub-study. Atherosclerosis. 2021 Oct;334:17-22. doi: 10.1016/j.atherosclerosis.2021.08.022. Epub 2021 Aug 14.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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The Lipid-Rich Plaque Study of vulnerable plaques and vulnerable patients: Study design and rationale. Am Heart J. 2017
Identification of patients and plaques vulnerable to future coronary events with near-infrared spectroscopy intravascular ultrasound imaging: a prospective, cohort study. Lancet. 2019
Other Identifiers
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The LRP Study
Identifier Type: -
Identifier Source: org_study_id
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